Trial of Screening for ALOA-IgG AtheroAbzyme Test (OP512011)

Omicron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Myocardial Ischemia; Acute Coronary Syndrome

Treatments: Device: ALOA IgG-AtheroAbzyme; Device: ALOA IgG-Elisa

Study type: Interventional

Funder types: Industry

Identifiers

NCT01272986

OP512011

Details and patient eligibility

About

This is a trial of screening for ALOA-IgG AtheroAbzyme Test comparing healthy, asymptomatic myocardial ischemic and acute coronary syndrome patients.

Enrollment: 100 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy patients
• High Risk patients or Asymptomatic myocardial Ischemic patients
• Acute Coronary Syndrome patients

Exclusion criteria

• None

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups, including a placebo group

Healthy patients

Placebo Comparator group

Treatment:

Device: ALOA IgG-Elisa

Device: ALOA IgG-AtheroAbzyme

Asymptomatic myocardial Ischemic patients

Active Comparator group

Treatment:

Device: ALOA IgG-Elisa

Device: ALOA IgG-AtheroAbzyme

Acute Coronary Syndrome Patients

Active Comparator group

Treatment:

Device: ALOA IgG-Elisa

Device: ALOA IgG-AtheroAbzyme